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Compliance for Biopharmaceutical API Process Validation

Approximate Time:  2 days (including class exercise)

Course Description:

Firms manufacturing biotechnology-derived pharmaceuticals face special requirements in the validation of their processes and rigorous scrutiny from Regulatory Agencies that are well aware of the extent to which the process defines the product in this field.  This course reviews and interprets the specific regulatory requirements, provides examples of the required documentation, and discusses current industry trends and regulatory hot topics. 

One of the recent FDA initiatives is to incorporate quality by design during product development.  A rational approach is presented to include consideration for Process Validation in all aspects of development including describing the Quality Assurance role, what must be accomplished as early as the process development lab bench, compliance considerations for raw materials, how process tolerances and uncertainties affect critical parameter ranges, analytical laboratory issues, scale up issues, and considerations in technology transfer.

Special emphasis is given to parameter selection and evaluation, such as determining criticality, how to set valid ranges and when to use worst case studies.  A hands-on exercise is used to reinforce the concepts using example process data and validation reports.  In addition to demonstrating that the process itself is under control, several key additional process characterization studies are required for biopharmaceuticals.  Critical elements for these studies are discussed including genetic stability, DNA and host-cell protein removal, clearance of process additives, viral clearance/inactivation, process pool hold times, buffer hold times, chromatography cleaning, storage and reuse, and membrane cleaning and reuse.  The types of support systems required, such as data collection and retrieval, are also presented.

Course Topics include (Complete Detailed Outline):

bulletRegulatory Requirements and Compliance Overview
bulletEvaluating Critical and Non-Critical Process Parameters
bulletCase Study:  FMEA (Failure Mode and Effect Analysis)
bulletQuality by Design:  Lab Bench to Market Production
bulletCase Study: Evaluating Data to Finalize Parameter Acceptable Ranges and Master Batch Production Records
bulletProcess Validation Support Studies
bulletCurrent FDA Issues and Hot Topics


Learning Objectives:

This course is designed to provide a basic overview of issues and compliance requirements specific to validating a biopharmaceutical manufacturing process.  Attendees will learn critical elements for review and/or inclusion in Process Validation documentation including protocols and reports. 


Who Should Attend:

Personnel in Development, Manufacturing, Validation, QA, and QC involved in process validation and process control should attend. Course assumes the attendee has a basic understanding of the GMP regulations.

NOTE:  This course is also offered as a two hour overview.  The same material is covered, but with fewer details and no class exercises.

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Did you know?

If Process Validation program deficiencies are found during FDA's product review or PreApproval Inspection, it typically results in approximately a one year delay to approval of a new product.


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